Manufacturing Specialist
Rockville , Maryland
December 14, 2017
Basic qualifications:
BA / BS in a scientific or technical discipline, and 5+ years of demonstrated technical competency in biopharmaceutical manufacturing processing.
• Previous experience in a biopharmaceutical manufacturing facility (operations experience preferred)
• Previous experience in production control systems (Delta-V , CCDARTS, Unicorn, or similar)
• Previous experience in process deviation investigations and remediation
• Experience with SAP and SAP processes
• Previous experience authoring and/or revising technical documents
• Knowledge of cGMP requirements and practices and previous experience in a cGMP setting

Preferred qualifications:
• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time
• Strong organizational skills
• Excellent communication and technical writing skills
• Ability to support and/or lead system troubleshooting efforts
• Participate in cross-functional teams to solve production problems
• Must be willing to work shifts
• Ability to collect, assess, and generate and depict conclusions from large quantities of production data

Reporting into the Specialist team, the role will assist with execution of the production schedule by troubleshooting and remediating operational and process issues, executing root cause investigations, owning/authoring deviations and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.

• Initiates Quality Records and conducts deviation investigations.
• Leads or assists in investigations including root cause analysis and assesses product impact using input from various departments
• Develops, executes and oversees CAPAs
• Supports Tech transfer and process monitoring support as needed
• Revision and management of manufacturing documents such as Batch Records and SOPs
• Leads or supports Continuous Improvement projects
• Conducts data gathering, trending, and data presentation as needed to support investigations
• Assists with shutdown/changeover and campaign scheduling and schedule management
• Support internal and external audits as needed

Contact information:

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